Reporting by Consumers

1.What kind of cases should I report?

You are encouraged to report all cases where either a healthcare professional or the registration holder believes that there is a possible causal relationship between the reaction and the drug in question. However, all cases which are serious and unexpected must be reported.

Cases of overdose (accidental or intentional) that lead to suspected serious and unexpected adverse drug reactions (ADR) or cases of lack of efficacy should also be reported.

You may also report ADR caused by using non-registered product or cosmetic product.

2.What kind of cases do I not need to report?

Reports on pregnancy should not be forwarded before the outcome is known, unless unintended pregnancy is suspected as an adverse reaction.

When using cytotoxic drugs or other preparations of a highly toxic nature, it will not be necessary to report those serious reactions which are well known to be frequent.

3.How do I report a side effect or ADR?

1. If you encounter any side effects or adverse drug reactions (ADRs), you may consult the doctor/pharmacist/nurse at the healthcare facility where you obtained your medicine, and they can help you report the ADR.

2. You can also report an ADR using the Consumer Side Effect Reporting Form (ConSERF). Please go to NPRA portal > Public > Reporting. There are a few ways to make a ConSERF report.

i. Online reporting.

OR

ii. Download the ConSERF form, fill in and submit via any one of these methods:

Please provide as much detail as possible, by completing all the information as required in the form.

4.Who do I contact if I have any queries?

For any queries, you can call our general line at 03-78835400 and ask for the Pharmacovigilance Section.

1. Is reporting of AEFI different from reporting ADR?

Reporting of AEFI is similar to reporting of ADR. They differ in the type of information which are important in order to facilitate investigation of the events.

2. What is the important information required for reporting of AEFI?

Apart from the information that is important for ADR reporting, the following information is especially important for reporting of AEFI:

Your contact number

Healthcare facility of vaccination taken

As the officer will need to contact you and the healthcare facility.

3. What are the cases that need to be reported?

Cases with any adverse event occurring after the administration of a vaccine need to be reported.

4. How can I report AEFI cases?

If you encounter any side effects or adverse drug reactions after vaccination, you may refer back to the doctor/pharmacist/nurse at healthcare facility where you get your vaccine from. You can also report any ADR by using Reporting Form for Medicine Complaint by Consumers (BPFK 419). Please download the form from www.bpfk.gov.my and send via any one of these methods upon completion: